Lead Validation Engineer

This is a fully remote position, open to applicants in Ireland, +1 more country.

📋 Description

• Oversee validation efforts for the Dotmatics Luma platform and internal systems operating in compliance with GxP standards.

• Act as the subject matter expert in computer system validation (CSV).

• Ensure that software development, testing, and deployment activities adhere to relevant regulations and standards.

• Create, review, and authorize validation lifecycle documentation, which includes Validation Master Plans, User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Traceability Matrices, Risk Assessments, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports.

• Collaborate with software quality and DevOps teams to utilize automated tools such as Cypress for validation protocols.

• Implement GAMP 5 principles to define validation strategies and documentation needs.

• Mentor and guide junior validation team members and QA personnel.

• Offer validation advice and training to engineers, QA analysts, and project managers.

• Assist with customer-facing validation efforts, validation testing, defect resolution, CAPA investigations, and audit responses.

• Work alongside Quality Management to ensure document control, conduct periodic reviews, and maintain audit readiness.

⛳️ Requirements

• In-depth knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and GxP requirements as they relate to software systems.

• Understanding of ISO 9001 quality management system principles.

• Proven experience in authoring and executing IQ/OQ/PQ protocols, traceability matrices, and validation summary reports.

• Proficiency in using automated testing tools such as Cypress or Playwright to produce and capture test evidence.

• Familiarity with the software development lifecycle (SDLC) and Agile methodologies.

• Experience in validating cloud-based systems, SaaS applications, or commercial off-the-shelf (COTS) software.

• A Bachelor’s degree in Computer Science, Biology, Chemistry, Engineering, or a related field is preferred but not mandatory.

• Experience in regulated life sciences environments, including pharmaceutical, biotech, or medical device industries.

🏝️ Benefits

• Remote-friendly work environment.

• Equal opportunity employer.

• Supportive and welcoming workplace culture.

• Collaborative global team dynamics.

• Opportunity to make a significant impact on scientific innovation.